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Patients* No. Clinical Trials* 26 Outlook 27 Outlook Immutep is well funded with a cash runway to calendar Q4 2019, well beyond the final progression free survival data from its Phase IIb AIPAC breast cancer trial. Potential News Flow and Milestones Clinical Other AIPAC fully recruited (226 patients): H2 2018 TACTI mel data from fourth patient cohort (30 mg dose at cycle 1): H2 2018 TACTI 002 to commence, Phase II trial in collaboration with MSD: H2 2018 IMP761 preclinical data: 2018 INSIGHT single cases from study: throughout 2018 AIPAC final progression free survival data (metastatic breast cancer trial): H1 2019 Potential milestone payments from clinical partners as trials progress Continued expansion of patent portfolio Continued regulatory interaction Ongoing business development activities 28 The global leader in developing LAG 3 therapeutics for immuno oncology and autoimmune diseases Deep expertise and IP in the LAG 3 immune control mechanism Broadest LAG 3 portfolio with four product candidates, three of which are in nine ongoing or planned clinical trials Multiple industry partnerships including Merck (MSD), GSK and Novartis Expecting clinical results, regulatory updates, and business development news flow in 2018 2019 Investment Highlights 29 Thank you!
LAG525 (IMP701) MK4280 FS 118 SYM022 413 55 51 F Star Symphogen A/S Armo Biosciences BI 754111 2 trials MGD013 131 Macrogenics 1 trial 1 trial 1 trial 1 trial 379 B.I. Merck Co. Inc. 4 trials 2 trials 1 trial 1 trial REGN3767 TSR 033 546 260 1 trial 1 trial Regeneron/ Sanofi Tesaro 906 30 INCAGN02385 Relatlimab 6739 BMS 6 trials 2 trials 10 trials 666 1 trial 2 trials GSK2831781 (IMP731) 67 1trial Program IMP761 AM003 25 Increasing Clinical Trials Targeting LAG 3 Industry increasingly deploying resources to development of LAG 3 therapeutics Sources: GlobalData, company websites, clinical trials.gov, and sec.gov Information as of August 17, 2018 *2018 includes planned and completed trials, includes trials where the company may not be the sponsor 1 4 7 14 20 38 1,000 1,539 2,895 4,754 5,630 10,243 0 2,000 4,000 6,000 8,000 10,000 12,000 0 5 10 15 20 25 30 35 40 2013 2014 2015 2016 2017 2018 Total Est.
Est. Dec 2016; aims to develop cancer drugs discovered by artificial intelligence Multiple Material Transfer Agreements Preclinical and clinical research ongoing Eftilagimod Alpha Partnerships Strategic supply partnership for the manufacturing of eftilagimod alpha Through WuXi, Immutep was first company ever to import and use a Chinese manufactured biologic in a European clinical trial 19 IMP731 (Autoimmune Diseases) 20 GSK 781 for Autoimmune Diseases GSK2831781, which is derived from IMP731 antibody, aims to kill the few activated LAG 3 + T cells that are auto reactive in autoimmune disease leading to long term disease control without generalized immune suppression GSK holds exclusive WWW rights Jan 2015: Immutep received a single digit million US$ milestone payment Up to 64m in total upfront payments and milestones, plus royalties if all objectives are achieved GSK2831781 in Phase Ib trials Phase 1 study completion date: March 2018 (see http://www.gsk clinicalstudyregister.com/study/200630#ps ) 21 IMP701 (Cancer) 22 IMP701 (LAG525) for Cancer IMP701 is an anti LAG 3 mAb that blocks LAG 3 mediated immune down regulation LAG 3 is a prime target for immune checkpoint blockade as it is readily expressed at a high level in many human tumors Novartis holds exclusive WW rights August 2015: Start of Phase I study of IMP701 in combination with PDR001 (anti PD 1 mAb) in 13 different cancer indications in 240 patients 1st and 2nd Milestone payments received in Aug 2015 and August 2017, respectively Estimated study completion date is April 2019 December 2017: new Phase II study of IMP701 in combination with PDR001 in advanced solid and hematologic malignancies in 160 patients made public April 2018: two new Phase II combination studies made public that planned to begin in June/ July 2018 in triple negative breast cancer (126 patients) and metastatic melanoma (160 patients) 23 Market Competition 24 LAG 3 Therapeutic Landscape Overview Immutep is the leader in developing LAG 3 modulating therapeutics Sources: GlobalData, company websites, clinical trials.gov, and sec.gov Information as of August 17, 2018, includes planned and completed trials, includes trials where the company may not be the sponsor Indicates one product; size indicates stage of development, green = product either developed by Immutep or under license from Immutep Indicates No. of patients on trials Phase 1 Preclinical Phase 2 Late stage Total estimated patients* Program Company Phase 1 Preclinical Phase 2 Pivotal Total estimated patients* Program Company Phase 1 Preclinical Phase 2 Pivotal Company Eftilagimod Alpha (IMP321) Incyte Corp.
Efti (IMP321) + Pembrolizumab (Keytruda ) for 12 months + max. of 12 months pembrolizumab monotherapy 12 15 sites in Europe / US / Australia IND in the U.S. granted in July 2018 Study start expected Q.4 18 First DMC meeting planned mid 19 First data expected mid 19 Status Report Efti (IMP321) Clinical Development TACTI 002 Trial Design Notes NSCLC non small cell lung cancer, HNSCC head and neck squamous cell cancer, DMC data monitoring comittee, PFS progression free survival, OS overall survival, PK pharmacokinetics, PD X any PD 1 or PDL 1 treatment nd nd 18 Eddingpharm holds Chinese rights Chinese IND for IMP321 granted in Dec 2017 USD1m milestone paid to Immutep EOC, an Eddingpharm spin off holding the Chinese rights for IMP321, Phase I study in MBC expected to start Sep 2018 Milestone and royalty bearing partnership for Immutep Spin off from NEC, Japan.
Performed analysis of read outs starting from cycle 1 day 1 of pembrolizumab, including the 4 cycles pembrolizumab monotherapy ( C1/D1 Analysis ) Efti (IMP321) in Melanoma Response Analysis Starting Cycle 1 Day 1 Pembrolizumab Notes (1) Response rates determined by C1/D1 Analysis (2) Includes 1 patient with complete disappearance of all target lesions, CR acc to RECIST1.1 16 In March 2018 Immutep entered into clinical trial collaboration and supply agreement with Merck Co., Inc., Kenilworth, NJ, USA (known as MSD outside the United States and Canada) to evaluate the combination of eftilagimod alpha with MSD's anti PD 1 therapy KEYTRUDA (pembrolizumab) in a new Phase II clinical trial The planned Phase II combinatory clinical trial, referred to as TACTI 002, will evaluate the safety and efficacy of this novel immunotherapy combination in patients in different cancer indications such as head and neck small cell carcinoma ( HNSCC ) or two different lines of non small cell lung cancer ( NSCLC ) The TACTI 002 clinical trial will be a Phase II, Simon two stage, non comparative, open label, single arm, multicenter clinical study Up to 110 patients across the three indications are planned to be treated in medical centers in Europe and the United States with the trial expected to commence in the second half of 2018 Collaboration and Supply Agreement 17 TACTI 002; a basket trial: Two ACTive Immunotherapeutics in different indications Phase II, multi national (EU + US + AUS), open label Simons 2 stage; 3 indications; up to 110 pts Response rate; PFS, OS, PK, Biomarker; Safety and tolerability Primary Objective Response rate (iRECIST) Other Objectives Safety, PFS+OS, PK, exploratory biomarker analysis Patient Population Part A: 1 line NSCLC PD X naive Part B: 2 line NSCLC, PD X refractory Part C: 2 line HNSCC, PD X naive Treatment 30 mg Efti (IMP321) s.c. 200 mg Pembrolizumab i.v.
Efficacy Metastatic Breast Cancer Observed response rates are substantially better than the 22 33% response rates seen in historical control groups with paclitaxel monotherapy Phase I, multicenter, open label, dose escalation 24 patients, 4 cohorts of 6 patients Efti (IMP321) + anti PD 1 (Keytruda ) Recommended Phase II dose, safety and tolerability Efti (IMP321) in Melanoma TACTI mel (IO combination) Trial Design 7 sites in Australia TACTI mel = Two ACTive Immunotherapeutics in melanoma preliminary data, status 17th August 2018 Part A: efti (IMP321) at 1, 6 and 30 mg s.c. every 2 weeks starting with cycle 5 of pembrolizumab Status: recruitment completed; interim results on next slides Part B: efti (IMP321) at 30 mg s.c. every 2 weeks starting with cycle 1 of pembrolizumab Status: recruitment completed; data expected Q4 Pembrolizumab (Keytruda ) 2 mg/kg every 3 weeks i.v. part A and B 12 Recommended dose for Phase II with efti (IMP321) + pembrolizumab Safety + tolerability Primary Objective Other Objectives PK and PD of IMP321, response rate, time to next treatment, PFS 13 Best Overall Response acc. to irRC N = 18 (%) irCR 1 (6 %) irPR# 5 (28 %)# irSD 6 (33 %) irPD 6 (33 %) Best overall response rate (ORR) 6 (33 %) Patients with tumor shrinkage 9 (50 %) Disease control rate 12 (66 %) Baseline Characteristics N = 18 (%) Elevated LDH 7 (39%) Metastasis stage M1c 15 (83 %) Pre treated with BRAF/MEK/ipilimumab 4 (22 %) irPD/irSD to pembro after 3 cycles 12 (67 %) # incl. 1 pt with complete disappearance of all target lesions; CR acc. to RECIST 1.1 Waterfall Plot* (starting after 4 cycles of pembrolizumab) Patients very late stage of disease (M1c, elevated LDH) Majority not responding to pembrolizumab Tumor shrinkage in 50 % of these patients incl. 2 pts with complete disappearance of all target lesions Efti (IMP321) in Melanoma TACTI mel (IO combination) Results after Start of Combo (1) preliminary data, status 9th May 2018 * acc to irRC Efficacy: Metastatic Melanoma All lesions disappeared CR (confirmed) patient without treatment and disease free Tumor progression preliminary data, status 9th May 2018 Efti (IMP321) in Melanoma TACTI mel (IO combination) Single Case at 1 mg efti 14 15 Best Overall Response acc. to irRC (C1/D1 analysis) (1) N = 18 (%) irCR 1 (6%) (1) irPR# 10 (56%) (1),(2) irSD 5 (28%) (1) irPD 2 (11%) (1) Best overall response rate (ORR) 11 (61%) (1) Progression free at 6 months 12 (66%) (1) preliminary data, status 9th May 2018 Overall response rate is 61% and 66% of patients are progression free 6 months after start of pembrolizumab (1) 7/12 (58 %) patients with progression (irPD) or stable disease (irSD) have a benefit by adding IMP321 (1) Trial Design TACTI mel: Combination treatment of efti and pembrolizumab starts at cycle 5 in patients not responding well or progressing on pembrolizumab difficult to compare to any historical control How does the efficacy look from the start of pembrolizumab?
To RECIST 1.1 Response Parameter Paclitaxel + IMP321 (n = 15) Complete Response (CR) 0/15 (0%) Partial Response (PR) 7/15 (47%) Stable Disease (SD) 6/15 (40%) Progressive Disease (PD) 2/15 (13%) Overall Response Rate (ORR) 7/15 (47%) Disease Control Rate (DCR) 13/15 (87%) ORR of 47% and DCR of 87% Two of the responses occurred relatively late (after ~6 months) ORR* of 47% and DCR** of 83% Responders had further tumor shrinkage between months 3 and 6 *Overall Response Rate **Disease Control Rate Phase I (n=30) AIPAC Safety Run Phase (n=15) Eftilagimod Alpha Prelim.
IO, chemo, vaccines or in situ immunization) Antigen presenting cell activation mechanism of action, that results in t cell cascade and thereby enhances the immune system response Potentially favorable (low) cost of goods based on current flat dosing regimen and manufacturing process Opportunity for Eftilagimod: Potential synergistic effect with current IO, cancer vaccines, or chemo therapies Unique Mode of Action and potential therapeutic synergies European Phase IIb trial of efti + chemo in breast cancer Dose escalation Phase I of efti + Keytruda (TACTI mel) in melanoma extension to other indications possible Opportunity for Eftilagimod Alpha Eftilagimod has the potential to be an ideal combination candidate in oncology therapy that could improve the prognosis for patients 10 Arm 1 , 113 patients : paclitaxel + IMP321 Phase IIb, multinational, randomized, double blind Safety run in, 15 (6+9) patients, 2 cohorts Stage 2 Arm 2 , 113 patients : paclitaxel + placebo Run in: recommended Phase II dose (RP2D) Stage 2: Efficacy (PFS) Eftilagimod Alpha in MBC (AIPAC) (chemo immunotherapy) AIPAC trial (Phase IIb): Active Immunotherapy PAClitaxel, MBC patients, different EU countries Status Report (August 2018) Safety run in completed successfully Randomized phase started early 2017 with the RP2D (30 mg) Interim data of safety run in presented at ASCO 2017 To date, efficacy and safety data in line with historical control group/ prior clinical trials (Brignone et al Journal Translational Medicine 2010, 8:71) Regulatory approval to conduct trial in 7 EU countries Over 30 sites actively recruiting patients Mid point of patient enrolment reached (June 2018) Primary read out expected in 2019 Primary Objective Run In: Recommended Phase II dose (RP2D) Stage 2: Efficacy (PFS) of paclitaxel + IMP321 vs. paclitaxel + placebo Other Objectives Anti tumor activity, safety and tolerability, pharmacokinetic and immunogenic properties, quality of life of IMP321 plus paclitaxel compared to placebo Patient Population Advanced MBC indicated to receive 1 line weekly paclitaxel Treatment Run in: Paclitaxel + IMP321 (6 or 30 mg) Arm 1: Paclitaxel + IMP321 (30 mg) Arm 2: Paclitaxel + Placebo Countries NL, BE, PL, DE, HU, UK, FR overall 30+ sites st 11 Preliminary data, status Interim CSR April 2018, best response acc.
Vol. (3 months) (as at 30 June 2018) 5.2 million ordinary shares on ASX 77 k ADRs on NASDAQ Shareholders Capital Structure 75% 25% Australian Securities Exchange Nasdaq 3 4 LAG 3 Overview Product Candidates 5 LAG 3 is widely expressed on tumor infiltrating lymphocytes (TILs) and cytotoxic T cells Prime target for an immune checkpoint blocker Functionally similar to CTLA 4 (targeted by Yervoy ) and PD 1 (targeted by Keytruda ) There are currently no approved therapeutics targeting LAG 3 Positive regulation of antigen presenting cells (APC) increase in antigen presentation to cytotoxic CD8 + T cells Negative regulation of LAG 3 + T Cells LAG 3 as a Therapeutic Target LAG 3/ MHC Class II Interaction T Cell APC MHCII LAG 3 6 IMMUNOSTIMULATION IMMUNOSUPPRESSION APC MHCII IMP321 LAG 3 T Cell T Cell IMP761 APC Activator Antagonistic mAb Agonistic mAb Immuno oncology Combination Therapies Viral Infections Rheumatoid Arthritis IBD Multiple Sclerosis Depleting mAb LAG 3 Partnered with Partnered with Targeting LAG 3 May Lead to Multiple Therapeutics in Numerous Indications IMP731 IMP701 Program Eftilagimod Alpha (LAG 3lg or IMP321), APC activating fusion protein AIPAC (Chemo IO Combo) TACTI mel (IO IO Combo) 2018/2019 2018/2019 INSIGHT (In situ Immunization) IMP731 (Depleting AB) IMP701 (Antagonist AB) Autoimmune Diseases IMP761 (Agonist AB) 2019/2020 TACTI 002 (IO IO Combo) (2) IO IO Combo: solid tumors IO IO Combo: solid tumors + blood cancer Chemo IO combo: metastatic breast cancer IO IO Combo: melanoma Commercial Rights/Partners Late Stage Phase II Preclinical Phase I Global Rights Global Rights Global Rights Global Rights Chinese Rights Notes (1) Expected timing of data readouts and actual results and timing may differ (2) In combination with KEYTRUDA (pembrolizumab) in non small cell lung carcinoma ( NSCLC ) or head and neck carcinoma ( HNSCC ); clinical trial is currently planned and not active (3) INSIGHT Investigator Initiated Trial ( IIT ) is controlled by lead investigator and therefore Immutep has no control over this clinical trial (4) Reflects completed study in psoriasis (5) Clinical trial is currently planned and not active * Cell Therapy: CVac divested to and controlled by Sydys Corporation 7 2019 (1) (1) (1) (1) Autoimmune Diseases (4) (3) (5) Oncology and Autoimmune Pipeline* 8 Lead Program Eftilagimod Alpha (IMP321) 9 Eftilagimod Key Characteristics (based on current data): Excellent safety profile and encouraging efficacy data thus far Potential for use in various combination settings (e.g.
Each ADR represents 100 ordinary shares Ticker symbols IMM (Australian Securities Exchange) IMMP (NASDAQ ADRs) Securities on issue (as at 17 August 2018) 3.0 billion ordinary shares 7.7 million issued ADRs Cash Term Deposits (1) (as at 30 June 2018) A$23.5 million (~US$17.4 million) Market Cap (as at 17 August 2018) A$105.9 million (~US$77.1 million) Avg.
Meaningful clinical, regulatory, and corporate news flow throughout calendar 2018 and 2019 Notes: (1) Cash balance does not include the A$1.9mm (US$1.4mm) R D rebate received from the French government (21 August 2018) Market capitalisation based on ASX ordinary share price. For a detailed summary of all securities on issue refer to latest Appendix 3B released on ASX.
Notice: Forward Looking Statements Company Snapshot Globally active biotechnology company with operations in Australia, Europe and U.S. Four LAG 3 related product candidates in development in immuno oncology and autoimmune disease Committed partnerships with three of the world s largest pharmaceutical companies Merck (MSD), Novartis and GSK, along with Eddingpharm in China Backed by high profile institutional healthcare investors: Platinum Asset Management and Australian Ethical in Australia, along with Ridgeback Capital in the U.S.
Additionally, the INSIGHT investigator sponsored clinical trial described in this presentation is controlled by the lead investigator and therefore Immutep has no control over this clinical trial. This presentation should not be relied on as a recommendation or forecast by Immutep. Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction.
Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks. Because actual results could differ materially to assumptions made and Immutep s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution.
No representation or warranty is made as to the accuracy, completeness or reliability of the information. Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside Immutep s control.
Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by Immutep and should not be relied upon as an independent source of information. Please refer to the Company's website and/or the Company s filings to the ASX and SEC for further information. The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified.
BioCentury 25th Annual NewsMakers in the Biotech Industry Conference New York 7 September 2018 (ASX: IMM, NASDAQ: IMMP) The global leader in developing LAG 3 therapeutics Exhibit 99.1 th 2 The purpose of the presentation is to provide an update of the business of Immutep Limited ACN 009 237 889 (ASX:IMM; NASDAQ:IMMP). These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification.